NCT03655106

Brief Summary

In patients with difficult IV access, ultrasound-guided catheter insertion is a preferred technique. However, many peripheral catheters fail and must be replaced, adding extra pain and difficulty for the patient, and requiring more healthcare provider time to maintain. In preliminary studies, we determined that catheters which extend further into the vein have a smaller failure rate. This study will compare two lengths of catheters to see if the longer catheters have better survival in a population of patients who have difficult IV access. Patients will be randomized to receive a standard length or extra-long venous catheter, which will be monitored daily for functionality during the patient's hospital course.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 11, 2020

Completed
Last Updated

March 11, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

August 29, 2018

Results QC Date

February 26, 2020

Last Update Submit

February 26, 2020

Conditions

Catheter Complications

Keywords

Ultrasound guided intravenous accessvascular accessextended dwell catheterIV survival

Outcome Measures

Primary Outcomes (1)

  • Duration of IV Survival

    Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.

    30 days

Secondary Outcomes (2)

  • Thrombosis

    30 days

  • Infection

    30 days

Study Arms (2)

Standard Long IV 4.78 cm 20 g catheter

ACTIVE COMPARATOR

Placement of Standard Long IV 4.78 cm 20 g catheter

Device: Standard Long IV 4.78 cm 20 g catheter

Ultra-Long IV 6.35 cm 20 g catheter

EXPERIMENTAL

Placement of Ultra-Long length IV 6.35 cm 20 g catheter

Device: Ultra-Long IV 6.35 cm 20 g catheter

Interventions

Standard Long IV 4.78 cm 20 g catheterDEVICE

Standard Long IV 4.78 cm 20 g catheter

Standard Long IV 4.78 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheterDEVICE

Ultra-Long IV 6.35 cm 20 g catheter

Ultra-Long IV 6.35 cm 20 g catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Self-reported difficult IV Access Patient and any one of the following:
  • Greater than 2 sticks in previous admission/hospital encounter
  • History of rescue vascular access device (such as US-guided IV, PICC line, midline, or CVC)
  • End-stage renal disease on dialysis
  • History of IV Drug Use
  • History of Sickle Cell Disease

You may not qualify if:

  • Age under 18 years old
  • Voluntary withdrawal or refusal to participate
  • Previous enrollment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

  • Bahl A, Hijazi M, Chen NW, Lachapelle-Clavette L, Price J. Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival. Ann Emerg Med. 2020 Aug;76(2):134-142. doi: 10.1016/j.annemergmed.2019.11.013. Epub 2020 Jan 16.

    PMID: 31955940DERIVED

MeSH Terms

Interventions

Catheters

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Amit Bahl, MD
Organization
William Beaumont Hospitals
amit.bahl@beaumont.edu
2488982245

Study Officials

  • Amit Bahl, MD

    Director of Emergency Ultrasound

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Emergency Ultrasound

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

October 29, 2018

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

March 11, 2020

Results First Posted

March 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)